Cardinal Health recalls Presource Fistulogram Packs with defective components
Cardinal Health is recalling Presource Fistulogram Packs containing recalled components including equipment drapes and table covers. Approximately 13,351 sterile packs distributed across 33 US states and Canada are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries mentioned in the source. The specific hazard presented by the recalled components is not detailed, indicating a theoretical risk.
Plain-English summary
Cardinal Health 200, LLC is recalling Presource Fistulogram Packs (Category SANOCFGHHA) that contain recalled components. The packs include equipment drapes, table covers, and surgical room turnover (SRT) kits.
Approximately 13,351 sterile packs were distributed nationwide across 33 US states and Canada. The affected packs are from Lot Number 23520 with an expiration date of February 1, 2025 (UDI-DI 10888439920840). Distribution occurred in Arizona, California, Colorado, Connecticut, Washington DC, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and West Virginia.
The FDA has classified this recall as Class II. The recall was issued under FDA recall number Z-0092-2024.
The recalled product
- Product
- Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 13,351
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #23520
- Exp. 2/1/2025
- UDI-DI 10888439920840.
Distribution
Part of a larger recall action
This product is one of 10 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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